Nitazoxanide Pharmacokinetic Parameters in Renal Impaired Subjects

An Open-label, Phase 1, Multiple-dose Study to Evaluate the Pharmacokinetics of Nitazoxanide 500 mg Twice Daily for 7 Days in Adult Subjects With Mild, Moderate, and Severe Renal Impairment and Adult Healthy Control Subjects

This study is being conducted to evaluate the major Nitazoxanide (NTZ) active metabolite in adult participants with renal impairment and healthy adults.

This study is being conducted to assess the pharmacokinetics of the major Nitazoxanide active metabolite as well as the safety and tolerability in renal impaired (mild, moderate and severe) and healthy matched control adults following repeated oral dose administration of NTZ 500 mg twice a day for 7 days.

Inclusion Criteria:

1. Males or females, between 18 and 80 years of age, inclusive
2. With a minimum body weight of ≥ 50.0 kg for males and ≥ 45.0 kg for females and within a BMI range of 18.0 to 40.0 kg/m^2, inclusive
3. Females participating in this study must be of non-childbearing potential or must be using highly effective contraception for the full duration of the study
4. Matched to subjects with mild, moderate and/or severe renal impairment in age (± 15 years), BMI (± 20%) and sex
5. The diagnosis of renal impairment has been stable, without significant change in overall disease status in the last 3 months prior to screening

Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

1. Positive serum pregnancy test at screening or positive urine pregnancy test
2. Having taken NTZ at any time prior to the first study drug administration
3. History of alcohol abuse within 1 year prior to screening
4. History of drug abuse within 1 year prior to screening or recreational use of soft drugs within 1 month or hard drugs within 3 months prior to screening
5. Excessive consumption of xanthine-based drinks (> 4 cups or glasses per day), food or beverages containing xanthine derivatives or xanthine-based compounds, 48 hours prior to the first dosing
6. Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to the first dosing
7. Strenuous exercise within 72 hours prior to check-in
8. History of a major surgical procedure within 30 days prior to screening
9. Presence or history of malignancy within the prior 3 years, with the exception of treated basal cell or squamous cell carcinoma
10. Poor peripheral venous access
11. Subjects who are taking warfarin or other highly plasma protein-bound drugs with narrow therapeutic indices

Other protocol-defined exclusion criteria may apply